Imaging protocols for navigated procedures

9732379 G02 Rev. 1 2015-11 Imaging protocols for navigated procedures How to use this document This document contains imaging protocols for navigated cranial, DBS and stereotactic, ENT, and spine procedures as well as instructions for placing skin fiducial markers. Work from left to right in the following table to determine which imaging protocol to use and to locate that protocol within this document. Anatomy Procedures Software in which the scans can be used Protocol Location in document Cranial Tumor resection, shunt placement, and biopsy procedures without a stereotactic frame Synergy Cranial Cranial Classic (MACH) PoleStar Navigation Cranial A Page 3 Synergy Cranial (This protocol does not apply if you are using Synergy Cranial software version 2.2.x or earlier.) Cranial B Page 6 DBS and stereotactic procedures FrameLink StimPilot Cranial C Page 12 Synergy Cranial (This protocol does not apply if you are using Synergy Cranial software version 2.2.x or earlier.) Cranial D Page 16 ENT Anterior skull base and sinus procedures Fusion ENT LandmarX element LandmarX env ENT Page 20 Spine All navigated spine procedures Synergy Spine Synergy Spine and Trauma Spine 3D Synergy Experience TLIF Procedure Solution Spine Page 23 If your site is using software that is not listed in the table, contact Medtronic Navigation to obtain the imaging protocol that applies to your software. The most common scan protocols are highlighted in blue. If you have questions about which protocol to use, contact your local Medtronic Navigation Clinical Specialist or call technical support at +1 800 595 9709 or +1 720 890 3160. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 1

Use the following tables to record the software versions installed on each navigation system at your site. Medtronic Navigation system name Cranial software version FrameLink software version ENT software version Spine software version Date Medtronic Navigation system name Cranial software version FrameLink software version ENT software version Spine software version Date Medtronic Navigation system name Cranial software version FrameLink software version ENT software version Spine software version Date 2 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial A protocol Cranial A protocol These requirements apply to scans that will be used in the following software: Procedures Procedures without a stereotactic frame Tumor resection Shunt placement Biopsy Software in which the scans can be used Synergy Cranial Cranial Classic (MACH) PoleStar Navigation Cranial A scan requirements Note: If you are using skin fiducial markers, follow the instructions for Fiducial marker placement for cranial scans on page 9. Contrast Contrast agents may be injected before scanning. Slices Scan contiguous slices. (Slice spacing must equal slice thickness. Make sure that there is no gap between slices.) 1 Correct: contiguous slices with no gap and no overlap 2 Incorrect: gap between slices 3 Incorrect: overlap of slices Use a constant slice thickness. Use a slice thickness of 1 mm or less, which usually produces the highest quality data set for surgical planning and navigation. - Any fractional slice thickness up to 3 mm is acceptable. However, as slice thickness increases, surgical planning and navigation performance can be impacted. - 3 mm is the largest slice thickness acceptable for cranial scans. Axial slices are preferred. Size and pixels Use a square image matrix of 256 x 256 pixels or 512 x 512 pixels. Use square pixels. Cranial A CT scans only Use a standard soft tissue algorithm. Do not use gantry tilt. Axial/helical scans are acceptable using a pitch ratio of 1:1. If you use helical scans, make sure that you do not see image artifacts in the reconstructed image slices. Use a circular (or square) field of view (FOV). Use the smallest FOV to encompass the region of interest, which is usually up to 25 cm (250 mm). Include the top of the head, the skull base, and the nose. If the scan will be merged with other scans using StealthMerge software, make sure that there is an air gap around the head. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 3

Cranial A protocol Cranial A MR scans only Scans to merge Scan region Do not use oblique slices. Scan along the axis of the magnet bore. Use single-echo scans. Do not use multi-echo scans. Any MR imaging sequence can be used to show anatomy/pathology. However, if the scans will be merged, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, and MRA have not been evaluated. Scans taken in the same Frame Of Reference as the MR-T1, MR-T2, MR- PD, or FLAIR may still be used if merged with Identity Merge. MR 3D volume acquisition is acceptable as long as the scan can be reconstructed in a way that conforms to all requirements of the imaging protocol. If you intend to merge two or more exams using StealthMerge software, ensure that multiple identifiable landmarks and the skull base are included in all of the scans to enable matching. CT, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, MEG, CTA, and MRA have not been evaluated. If you intend to merge O-arm exams with preoperative exams, you may use any imaging mode, except when using an O-arm O-1000 system. For O-arm O-1000 systems, use the high definition 3D or enhanced cranial 3D modes. Scan from the superior aspect of the horizontal portion of the mandible through the top or vertex of the cranium. Include an air gap above the superior aspect of the head. Include all fiducial markers, the ears, maxillary teeth, and the tip of the nose. Ensure that the tip of the patient's nose is included in the scan and that it is the most anterior point on the scan. Also, start the scan above any dental work to avoid creating artifacts. This image shows the typical scan region for cranial scans (unless the lesion is very low). Patient position Archive format Separate the patient s head from the scanner headrest with towels or foam. Use padding to prevent patient motion, but make sure that the padding does not distort the fiducial markers or the skin. Make sure that the patient's ears do not touch the sides of the headrest, and that they are not pushed away from their normal position. Archive the scan in an uncompressed file format. 4 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial A protocol Cranial A scan examination The surgeon or imaging technologist should examine the completed scan to verify the following quality criteria: The patient image orientation is correct. The total pathology/region of interest is visible. The planned surgical target and entry points are visible. The tip of the patient's nose is included in the scan and should be the most anterior point on the scan. Having the tip of the patient s nose as the most anterior point on the scan is preferred for the Tracer registration method. The slice thickness is constant throughout the scan. No motion artifact is present. Rapidly scroll through the images to make sure they all line up. Be aware of phase encoding (ghost) artifacts. If necessary, work with radiology to reduce artifacts. The fiducial markers are clearly visible and are not distorted. No gantry tilt was used. All other aspects of the imaging protocol were followed. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 5

Cranial B protocol Cranial B protocol Procedures Procedures without a stereotactic frame Tumor resection Shunt placement Biopsy Software in which the scans can be used Synergy Cranial (This protocol does not apply if you are using Synergy Cranial software version 2.2.x or earlier.) Cranial B scan requirements Note: If you are using skin fiducial markers, follow the instructions for Fiducial marker placement for cranial scans on page 9. Contrast Contrast agents may be injected before scanning. Slices Scan contiguous slices. (Slice spacing must equal slice thickness. Make sure that there is no gap between slices.) 1 Correct: contiguous slices with no gap and no overlap 2 Incorrect: gap between slices 3 Incorrect: overlap of slices Use a constant slice thickness. Use a slice thickness of 1 mm or less, which usually produces the highest quality data set for surgical planning and navigation. - Any fractional slice thickness up to 3 mm is acceptable. However, as slice thickness increases, surgical planning and navigation performance can be impacted. - 3 mm is the largest slice thickness acceptable for cranial scans. Axial slices are preferred. Size Use a square or rectangular image matrix of up to 1024 x 1024 pixels. Note: Scans that are larger than 512 x 512 pixels cannot be used in Synergy Cranial software version 2.2.x or earlier. 6 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial B protocol Cranial B CT scans only Cranial B MR scans only Scans to merge Scan region Use a standard soft tissue algorithm. Do not use gantry tilt. Axial/helical scans are acceptable using a pitch ratio of 1:1. If you use helical scans, make sure that you do not see image artifacts in the reconstructed image slices. Use a circular (or square) field of view (FOV). Use the smallest FOV to encompass the region of interest, which is usually up to 25 cm (250 mm). Include the top of the head, the skull base, and the nose. If the scan will be merged with other scans using StealthMerge software, make sure that there is an air gap around the head. Do not use oblique slices. Scan along the axis of the magnet bore. Use single-echo scans. Do not use multi-echo scans. Any MR imaging sequence can be used to show anatomy/pathology. However, if the scans will be merged, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, and MRA have not been evaluated. Scans taken in the same Frame Of Reference as the MR-T1, MR-T2, MR- PD, or FLAIR may still be used if merged with Identity Merge. MR 3D volume acquisition is acceptable as long as the scan can be reconstructed in a way that conforms to all requirements of the imaging protocol. If you intend to merge two or more exams using StealthMerge software, ensure that multiple identifiable landmarks and the skull base are included in all of the scans to enable matching. CT, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, MEG, CTA, and MRA have not been evaluated. If you intend to merge O-arm exams with preoperative exams, you may use any imaging mode, except when using an O-arm O-1000 system. For O-arm O-1000 systems, use the high definition 3D or enhanced cranial 3D modes. Scan from the superior aspect of the horizontal portion of the mandible through the top or vertex of the cranium. Include an air gap above the superior aspect of the head. Include all fiducial markers, the ears, maxillary teeth, and the tip of the nose. Ensure that the tip of the patient's nose is included in the scan and that it is the most anterior point on the scan. Also, start the scan above any dental work to avoid creating artifacts. This image shows the typical scan region for cranial scans (unless the lesion is very low). 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 7

Cranial B protocol Patient position Archive format Separate the patient s head from the scanner headrest with towels or foam. Use padding to prevent patient motion, but make sure that the padding does not distort the fiducial markers or the skin. Make sure that the patient's ears do not touch the sides of the headrest, and that they are not pushed away from their normal position. Archiving the scan in an uncompressed file format is preferred. If you compress the scan, use a lossless compression method, such as, JPEG lossless or JPEG2000 lossless. Note: Compressed scans cannot be used in Synergy Cranial software version 2.2.x or earlier. Cranial B scan examination The surgeon or imaging technologist should examine the completed scan to verify the following quality criteria: The patient image orientation is correct. The total pathology/region of interest is visible. The planned surgical target and entry points are visible. The tip of the patient's nose is included in the scan and should be the most anterior point on the scan. Having the tip of the patient s nose as the most anterior point on the scan is preferred for the Tracer registration method. The slice thickness is constant throughout the scan. No motion artifact is present. Rapidly scroll through the images to make sure they all line up. Be aware of phase encoding (ghost) artifacts. If necessary, work with radiology to reduce artifacts. The fiducial markers are clearly visible and are not distorted. No gantry tilt was used. All other aspects of the imaging protocol were followed. 8 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Fiducial marker placement for cranial scans Fiducial marker placement for cranial scans Note: The following instructions apply to skin fiducial markers (960-991). If you are using a different kind of fiducial marker, follow these recommendations as well as any recommendations from the fiducial marker manufacturer. Although imaging may occur at any time prior to surgery, fiducial markers must remain fixed from the time of scanning until after registration in the navigation software. Instruct the patient not to remove or alter the position of the markers. If a marker falls off after the patient has been scanned, leave it off. Good fiducial marker placement Follow these best practices for fiducial marker placement for Touch-n-Go registration or PointMerge registration. Place 7 to 11 fiducial markers. Distribute the fiducial markers around the patient s head. Choose locations where the skin is taut. Avoid areas with loose skin such as the cheeks and under the eyes. Choose locations where the fiducial markers will not be depressed or shifted when the patient is lying in the scanner or when the patient is positioned for surgery. The mastoid behind the ear is an ideal location for fiducial markers. Place the markers high enough on the mastoid that the scan will encompass them. Place more fiducial markers near the surgical area of interest. It may be helpful to place 2 markers near each other on one side of the head to help the surgeon confirm correct image orientation. Examples of good fiducial marker placement 1 Good fiducial marker placement for anterior and lateral surgical approaches 2 Good fiducial marker placement for posterior surgical approaches 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 9

Fiducial marker placement for cranial scans Poor fiducial marker placement Do not place all fiducial markers in one concentrated location or on one side of the head. Do not place fiducial markers in a symmetrical pattern. That is, do not place markers in the same locations on both sides of the head. Also, do not place the markers such that they form squares or triangles with equal-length sides. Do not place fiducial markers in a repeating pattern. Do not place fiducial markers in a straight line. 10 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Fiducial marker placement for cranial scans Placing fiducial markers To place the fiducial markers on the patient: 1. Choose a site where the skin is taut. Shave a small patch of hair (approximately one inch square) at the site where you will place the fiducial marker. 2. Clean the site with alcohol to strengthen the marker s adhesion to the skin. Allow the site to dry thoroughly. Note: If the patient is diaphoretic, you may wish to apply adhesive. 3. Remove the paper from the adhesive backing on the marker, and place the marker at the prepared site. Note: Make sure that the center dot is removed from the fiducial marker. 4. Mark the skin with an indelible ink pen through the hole in the center of the fiducial marker. 5. Place 7 to 11 markers in this manner. Distribute the markers around the patient s head as described in the best practices for fiducial marker placement. 6. Ensure positioning in the scanner does not shift any of the fiducial markers. 7. Image the patient according to the appropriate protocol given in this document. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 11

Cranial C protocol Cranial C protocol Procedures DBS and stereotactic procedures Software in which the scans can be used FrameLink StimPilot Cranial C scan requirements Note: If the patient has WayPoint anchors implanted for the STarFix platform, refer to the instructions for use of the anchors for additional scan requirements. WayPoint anchors and the STarFix platform are products of FHC, Inc. Contrast Contrast agents may be injected before scanning. Slices Scan contiguous slices. (Slice spacing must equal slice thickness. Make sure that there is no gap between slices.) 1 Correct: contiguous slices with no gap and no overlap 2 Incorrect: gap between slices 3 Incorrect: overlap of slices Use a constant slice thickness. Use a slice thickness of 1 mm or less, which usually produces the highest quality data set for surgical planning and navigation. - Any fractional slice thickness up to 3 mm is acceptable. However, as slice thickness increases, surgical planning and navigation performance can be impacted. - 3 mm is the largest slice thickness acceptable for use with the FrameLink and StimPilot software. Axial slices are preferred. Size and pixels Use a square image matrix of 256 x 256 pixels or 512 x 512 pixels. Use square pixels. Cranial C CT scans only Use a standard soft tissue algorithm. Do not use gantry tilt. Axial/helical scans are acceptable using a pitch ratio of 1:1. If you use helical scans, make sure that you do not see image artifacts in the reconstructed image slices. Use a circular (or square) field of view (FOV). Use the smallest FOV to encompass the region of interest, which is usually 28 cm to 32 cm (280 mm to 320 mm). Include AC/PC structures, target region, entry region (required for frameless scans), and stereotactic frame (required for the registration scan). 12 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial C protocol Cranial C MR scans only Scans to merge Scan region Do not use oblique slices. Scan along the axis of the magnet bore. Use single-echo scans. Do not use multi-echo scans. Any MR imaging sequence can be used to show anatomy/pathology. However, if the scans will be merged, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, and MRA have not been evaluated. Scans taken in the same Frame Of Reference as the MR-T1, MR-T2, or MR-PD may still be used if merged with Identity Merge. MR 3D volume acquisition is acceptable as long as the scan can be reconstructed in a way that conforms to all requirements of the imaging protocol. If you intend to merge two or more exams using StealthMerge software, ensure that multiple identifiable landmarks and the skull base are included in all of the scans to enable matching. CT, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, MEG, CTA, and MRA have not been evaluated. Scan from the superior aspect of the horizontal portion of the mandible through the top or vertex of the cranium. Include an air gap above the superior aspect of the head. Include bone fiducial markers, the ears, maxillary teeth, and the tip of the nose. Ensure that the tip of the patient's nose is included in the scan and that it is the most anterior point on the scan. Also, start the scan above any dental work to avoid creating artifacts. These images show the typical scan region for DBS scans. Include the localizer frame with the 9 required rods in a stereotactic scan (see Figure 1 on page 15 for more information). Minimize the angle between the vertical localizer rods and the superior-inferior image axis. 1 Scan region without localizer 2 Superior-inferior image axis 3 Ideal scan region with minimal localizer tilt 4 Too much angle between the vertical localizer rods and the superior-inferior image axis 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 13

Cranial C protocol Patient position Make sure that the patient anatomy is oriented as close as possible to LPS space (the left-right, anterior-posterior, and inferior-superior axes). Separate the patient s head from the scanner headrest with towels or foam. Use padding to prevent patient motion, but make sure that the padding does not distort the fiducial markers or the skin. Make sure that the patient's ears do not touch the sides of the headrest, and that they are not pushed away from their normal position. Archive format Archive the scan in an uncompressed file format. Cranial C scan examination The surgeon or imaging technologist should examine the completed scan to verify the following quality criteria: The patient image orientation is correct, and the patient anatomy is lined up with the left-right, anterior-posterior, and inferior-superior axes. The total region of interest is visible. The planned surgical target and entry points are visible. The tip of the patient's nose is included in the scan and should be the most anterior anatomical point on the scan. The slice thickness is constant throughout the scan. No motion artifact is present. Rapidly scroll through the images to make sure they all line up. Be aware of phase encoding (ghost) artifacts. If necessary, work with radiology to reduce artifacts. No gantry tilt was used. For stereotactic scans, the 9 required rods are visible and are in the correct orientation. Rods 1 through 9 (shown in Figure 1) are required for each frame. 14 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial C protocol 1: Figure 1: Rod numbering 1 Fischer frames 2 Leksell CT frames 3 Leksell MR frames 4 Integra CRW frame: BRW-LF (CRW is a trademark of Integra Burlington MA, Inc.) 5 Integra CRW frames: Luminant CT and UCLF CT Note: The rod numbers shown in parentheses may not be available on all versions of the frames. All other aspects of the imaging protocol were followed. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 15

Cranial D protocol Cranial D protocol Procedures DBS and stereotactic procedures Software in which the scans can be used Synergy Cranial (This protocol does not apply if you are using Synergy Cranial software version 2.2.x or earlier.) Cranial D scan requirements Note: If the patient has WayPoint anchors implanted for the STarFix platform, refer to the instructions for use of the anchors for additional scan requirements. WayPoint anchors and the STarFix platform are products of FHC, Inc. Contrast Contrast agents may be injected before scanning. Slices Scan contiguous slices. (Slice spacing must equal slice thickness. Make sure that there is no gap between slices.) 1 Correct: contiguous slices with no gap and no overlap 2 Incorrect: gap between slices 3 Incorrect: overlap of slices Use a constant slice thickness. Use a slice thickness of 1 mm or less, which usually produces the highest quality data set for surgical planning and navigation. - Any fractional slice thickness up to 3 mm is acceptable. However, as slice thickness increases, surgical planning and navigation performance can be impacted. - 3 mm is the largest slice thickness acceptable for cranial scans. Axial slices are preferred. Size Cranial D CT scans only Use a square or rectangular image matrix of up to 1024 x 1024 pixels. Note: Scans that are larger than 512 x 512 pixels cannot be used in Synergy Cranial software version 2.2.x or earlier. Use a standard soft tissue algorithm. Do not use gantry tilt. Axial/helical scans are acceptable using a pitch ratio of 1:1. If you use helical scans, make sure that you do not see image artifacts in the reconstructed image slices. Use a circular (or square) field of view (FOV). Use the smallest FOV to encompass the region of interest, which is usually 28 cm to 32 cm (280 mm to 320 mm). Include AC/PC structures, target region, entry region (required for frameless scans), and stereotactic frame (required for the registration scan). 16 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial D protocol Cranial D MR scans only Scans to merge Scan region Do not use oblique slices. Scan along the axis of the magnet bore. Use single-echo scans. Do not use multi-echo scans. Any MR imaging sequence can be used to show anatomy/pathology. However, if the scans will be merged, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, and MRA have not been evaluated. Scans taken in the same Frame Of Reference as the MR-T1, MR-T2, MR- PD, or FLAIR may still be used if merged with Identity Merge. MR 3D volume acquisition is acceptable as long as the scan can be reconstructed in a way that conforms to all requirements of the imaging protocol. If you intend to merge two or more exams using StealthMerge software, ensure that multiple identifiable landmarks and the skull base are included in all of the scans to enable matching. CT, MR-T1, MR-T2, MR-PD, FLAIR, and combinations thereof, have been evaluated and found effective for use with StealthMerge software. Other modalities such as SPGR, MPRAGE, MEG, CTA, and MRA have not been evaluated. If you intend to merge O-arm exams with preoperative exams, you may use any imaging mode, except when using an O-arm O-1000 system. For O-arm O-1000 systems, use the high definition 3D or enhanced cranial 3D modes. Scan from the superior aspect of the horizontal portion of the mandible through the top or vertex of the cranium. Include an air gap above the superior aspect of the head. Include bone fiducial markers, the ears, maxillary teeth, and the tip of the nose. Ensure that the tip of the patient's nose is included in the scan and that it is the most anterior point on the scan. Also, start the scan above any dental work to avoid creating artifacts. These images show the typical scan region for DBS scans. Include the localizer frame with the required rods in a stereotactic scan. If the frame will be registered manually in the software, rods 1 through 9 are required in the scan (see Figure 2 page 19 for more information). If the frame will be registered automatically in the software, at least 6 rods are required in the scan, and at least 1 of the 6 must be a diagonal rod. However, consider including rods 1 through 9 in case manual frame registration becomes necessary. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 17

Cranial D protocol Minimize the angle between the vertical localizer rods and the superior-inferior image axis. 1 Scan region without localizer 2 Superior-inferior image axis 3 Ideal scan region with minimal localizer tilt 4 Too much angle between the vertical localizer rods and the superior-inferior image axis Patient position Archive format Separate the patient s head from the scanner headrest with towels or foam. Use padding to prevent patient motion, but make sure that the padding does not distort the fiducial markers or the skin. Make sure that the patient's ears do not touch the sides of the headrest, and that they are not pushed away from their normal position. Archiving the scan in an uncompressed file format is preferred. If you compress the scan, use a lossless compression method, such as, JPEG lossless or JPEG2000 lossless. Note: Compressed scans cannot be used in Synergy Cranial software version 2.2.x or earlier. Cranial D scan examination The surgeon or imaging technologist should examine the completed scan to verify the following quality criteria: The patient image orientation is correct, and the patient anatomy is lined up with the left-right, anterior-posterior, and inferior-superior axes. The total region of interest is visible. The planned surgical target and entry points are visible. The tip of the patient's nose is included in the scan and should be the most anterior anatomical point on the scan. The slice thickness is constant throughout the scan. No motion artifact is present. Rapidly scroll through the images to make sure they all line up. Be aware of phase encoding (ghost) artifacts. If necessary, work with radiology to reduce artifacts. No gantry tilt was used. 18 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Cranial D protocol For stereotactic scans make sure that the required rods are visible and are in the correct orientation. If the frame will be registered manually in the software, rods 1 through 9 are required. If the frame will be registered automatically in the software, at least 6 rods are required in the scan, and at least 1 of the 6 must be a diagonal rod. However, consider including rods 1 through 9 in case manual frame registration becomes necessary. 2: Figure 2: Rod numbering 1 Fischer frames 2 Leksell CT frames 3 Leksell MR frames 4 Integra CRW frame: BRW-LF 5 Integra CRW frames: Luminant CT and UCLF CT Note: The rod numbers shown in parentheses may not be available on all versions of the frames. All other aspects of the imaging protocol were followed. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 19

ENT protocol ENT protocol Procedures Anterior skull base and sinus procedures Software in which the scans can be used Fusion ENT LandmarX element LandmarX env ENT scan requirements Contrast Contrast agents may be injected before scanning. Slices Scan contiguous slices. (Slice spacing must equal slice thickness. Make sure that there is no gap between slices.) 1 Correct: contiguous slices with no gap and no overlap 2 Incorrect: gap between slices 3 Incorrect: overlap of slices Use a constant slice thickness. Use a slice thickness of 1 mm or less, which usually produces the highest quality dataset for surgical planning and navigation. - Any fractional slice thickness up to 2 mm is acceptable. However, as slice thickness increases, surgical planning and navigation performance can be impacted. - 2 mm is the largest slice thickness acceptable for use with the ENT application. Axial slices are preferred. Size Use a square image matrix of 256 x 256 pixels or 512 x 512 pixels. Use square pixels. ENT CT scans only Use a standard soft tissue algorithm. Axial/helical scans are acceptable using a pitch ratio of 1:1. If you use helical scans, make sure that you do not see image artifacts in the reconstructed image slices. Use a circular (or square) field of view (FOV). Use the smallest FOV to encompass the region of interest, which is usually up to 25 cm (250 mm). Include the top of the head, the skull base, and the nose. If the scan will be merged with other scans using ENT Scan Merge software, make sure that there is an air gap around the head. Do not use gantry tilt. 20 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

ENT protocol ENT MR scans only Scans to merge Scan region Do not use oblique slices. Scan along the axis of the magnet bore. Use single-echo scans. Do not use multi-echo scans. Any MR imaging sequence can be used to show anatomy/pathology. However, if the scans will be merged, MR-T1, MR-T2, and combinations thereof, have been evaluated and found effective for use with ENT Scan Merge and StealthMerge ENT software. Other modalities such as SPGR, MPRAGE, and MRA have not been evaluated. MR 3D volume acquisition is acceptable as long as the scan can be reconstructed in a way that conforms to all requirements of the imaging protocol. If you intend to merge two or more exams using ENT Scan Merge or StealthMerge ENT software, ensure that multiple identifiable landmarks and the skull base are included in all of the scans to enable matching. CT, MR-T1, MR-T2, and combinations thereof, have been evaluated and found effective for use with ENT Scan Merge and StealthMerge ENT software. Other modalities such as SPGR, MPRAGE, MEG, CTA, and MRA have not been evaluated. Scan from the superior aspect of the horizontal portion of the mandible through the top or vertex of the cranium. Include an air gap above the superior aspect of the head. Include the skull base, the ears, maxillary teeth, and the tip of the nose. Ensure that the tip of the patient's nose is included in the scan and that it is the most anterior point on the scan. Also, start the scan above any dental work to avoid creating artifacts. The image below shows the typical scan region for ENT anterior skull base and sinus procedures. Patient position Archive format Place the patient s head on a headrest, a small firm donut, or a folded towel on the scanner table. If the patient cannot remain still, use a headrest. Separate the patient's head from the headrest with towels or foam. Use padding to prevent patient motion, but make sure that the padding does not distort or shift the skin. Make sure that the patient's ears do not touch the sides of the headrest, and that they are not pushed away from their normal position. Archive the scan in an uncompressed file format. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 21

ENT protocol ENT scan examination The surgeon or imaging technologist should examine the completed scans to verify the following quality criteria: The patient image orientation is correct. The total pathology/region of interest is visible. The planned surgical target and entry points are visible. The tip of the patient's nose is included in the scan and should be the most anterior point on the scan. Having the tip of the patient s nose as the most anterior point on the scan is preferred for the Tracer registration method. The slice thickness is constant throughout the scan. No motion artifact is present. Rapidly scroll through the images to make sure they all line up. Be aware of phase encoding (ghost) artifacts. If necessary, work with radiology to reduce artifacts. No gantry tilt was used. All other aspects of the imaging protocol were followed. 22 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Spine protocol Spine protocol Procedures All navigated spine procedures Software in which the scans can be used Synergy Spine Synergy Spine and Trauma Spine 3D Synergy Experience TLIF Procedure Solution Spine scan requirements Contrast Contrast agents may be injected before scanning. Slices Scan contiguous slices. (Slice spacing must equal slice thickness. Make sure that there is no gap between slices.) 1 Correct: contiguous slices with no gap and no overlap 2 Incorrect: gap between slices 3 Incorrect: overlap of slices Use a constant slice spacing. Use a slice thickness of 1 mm or less, which usually produces the highest quality data set for surgical planning and navigation. - Any fractional slice thickness up to 2 mm is acceptable. However, as slice thickness increases, surgical planning and navigation performance can be impacted. - 2 mm is the largest slice thickness acceptable for use with the Spine application. Axial slices are preferred. Size and pixels Use a square image matrix of 256 x 256 pixels or 512 x 512 pixels. Use square pixels. Spine CT scans only Use a standard soft tissue algorithm. Do not use gantry tilt. Axial/helical scans are acceptable using a pitch ratio of 1:1. If you use helical scans, make sure that you do not see image artifacts in the reconstructed image slices. Use a circular (or square) field of view (FOV). Use the smallest FOV to encompass the region of interest, which is usually up to 18 cm (180 mm). Completely encompass all vertebrae of interest, including the spinous and transverse processes. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 23

Spine protocol Spine MR scans only Do not use oblique slices. Scan along the axis of the magnet bore. Use single-echo scans. Do not use multi-echo scans. Any MR imaging sequence can be used to show anatomy/pathology. MR 3D volume acquisition is acceptable as long as the scan can be reconstructed in a way that conforms to all requirements of the imaging protocol. Scan region Scan coverage should include one-half vertebra above and below the region of interest. This image shows a sample scan region for a lumbar spine scan. 1 Vertebra of interest 2 Minimum scan region When imaging the sacrum, scan past and include the sciatic notches. Archive format Archive the scan in an uncompressed file format. Spine scan examination The surgeon or imaging technologist should examine the completed scan to verify the following quality criteria: The patient image orientation is correct. The total pathology/region of interest is visible. The planned surgical target and entry points are visible. The slice spacing is constant throughout the scan. No motion artifact is present. Rapidly scroll through the images to make sure they all line up. Be aware of phase encoding (ghost) artifacts. If necessary, work with radiology to reduce artifacts. No gantry tilt was used. All other aspects of the imaging protocol were followed. 24 Medtronic Navigation, Inc. 9732379 G02 Rev. 1

Transfer the scan Transfer the scan To transfer a scan to a StealthStation system, archive the scan from the scanner to a CDR/DVR or USB drive, or transfer the scan electronically to the Medtronic Computer-Assisted Surgery system via a DICOM network. Do not archive or transfer scout images. If the StealthStation system includes DICOM query software, users can query the PACS to retrieve images. Assistance For questions about the Imaging Protocols, contact your local Medtronic Navigation Clinical Specialist or call technical support at +1 800 595 9709 or +1 720 890 3160. 9732379 G02 Rev. 1 Medtronic Navigation, Inc. 25